DONABEL 2mg / 0.03mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Donabel 2 mg/0.03 mg film-coated tablets EFG

dienogest/ethinylestradiol

Important Things to Know About Combined Hormonal Contraceptives (CHCs)

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting the use of a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section "Blood Clots").

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Donabel and what is it used for
2. What you need to know before taking Donabel
3. How to take Donabel
4. Possible side effects
5. Storage of Donabel
6. Package contents and additional information

1. What is Donabel and what is it used for

Donabel is a medication

• to prevent pregnancy ("birth control pill").
• for the treatment of women with moderate acne who accept receiving a birth control pill after the failure of adequate local treatments or oral antibiotics.

It contains a small amount of female hormones, specifically progesterone (dienogest) and an estrogen (ethinylestradiol).

Birth control pills that contain two hormones are called "combined" pills or combined oral contraceptives.

Oral contraceptive pills (taken by mouth) are a very effective method of family planning. If taken regularly (without missing pills), the possibility of becoming pregnant is very low.

2. What you need to know before taking Donabel

General considerations

Before starting to take Donabel, you should read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 "Blood clots").

Before you can start taking Donabel, your doctor will ask you some questions about your personal medical history and that of your close relatives. The doctor will also measure your blood pressure and, depending on your personal situation, may perform some other tests.

This prospectus describes several situations in which you should stop taking this medication or in which its effectiveness is diminished. In such situations, you should not have sexual intercourse without taking additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use rhythm or temperature methods. These methods are unreliable because combined oral contraceptives alter the usual changes in temperature and cervical mucus that occur during the menstrual cycle.

Donabel, like other combined oral contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.

Your acne will normally improve within three to six months of treatment and may continue to improve even after six months. You should discuss with your doctor the need to continue treatment three to six months after its initiation and periodically thereafter.

Do not take Donabel

You should not take Donabel if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), lungs (pulmonary embolism, PE), or other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need an operation or spend a lot of time without getting up (see section "Blood clots").
• If you have ever had a heart attack or stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary stroke symptoms).
• If you have any of the following diseases that may increase your risk of forming a clot in the arteries:
• • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fat in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have or have had a hormone-dependent tumor (e.g., breast cancer or genital organ cancer).
• If you have or have had benign or malignant liver tumors.
• If you have or have had liver disease, which may cause yellowing of the skin (jaundice) or itching all over the body, and indicate an anomaly in liver function.
• If you have vaginal bleeding of unknown origin.
• If you are pregnant or think you may be pregnant.
• If you are allergic to ethinylestradiol, dienogest, or any of the other components of this medication (listed in section 6).

Do not take Donabel

• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Other medications and Donabel").

If you present any of the above situations, inform your doctor before starting to take Donabel. Your doctor may recommend another type of oral contraceptive or a non-hormonal contraceptive method. See also the section "General considerations".

Additional information on special populations

Children and adolescents

Donabel is not indicated for use in women (girls) who have not yet had their first menstrual period.

Older women

Donabel is not indicated for use after menopause.

Liver failure

Do not take Donabel if you have liver disease. See also "Do not take Donabel" and "Warnings and precautions".

Kidney failure

Consult your doctor. Available data do not indicate that it is necessary to change the use of Donabel.

Warnings and precautions

When should you consult your doctor?

Seek urgent medical attention

• If you notice possible signs of a blood clot that may mean you are suffering from a blood clot in your leg (i.e., deep vein thrombosis), a blood clot in your lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clots" below).

To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

If the combined pill is used by a woman who is also experiencing any of the conditions listed below, she may need to be monitored more closely.

Tell your doctor if you suffer from any of the following conditions

If the condition develops or worsens while you are taking Donabel, you should also inform your doctor.

• if you smoke;
• if you have diabetes mellitus;
• if you are overweight;
• if you have high blood pressure;
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• if you need an operation or spend a lot of time without getting up (see section 2 "Blood clots");
• if you have just given birth, you are at a higher risk of blood clots. You should ask your doctor when you can start taking Donabel after childbirth;
• if you have inflammation of the veins that are under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a heart valve disease or heart rhythm disorders;
• if any of your close relatives have had a blood clot (thrombosis in the lower limbs, lung - pulmonary embolism, or elsewhere), a heart attack, or a stroke at a young age;
• if a close relative has or has had breast cancer;
• if you have migraines;
• if you have epilepsy (see "Other medications and Donabel");
• if you have liver or biliary disease;
• if you have a disease that appeared for the first time during pregnancy or previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy called herpes gestationalis, a nervous disease called Sydenham's chorea);
• if you have brown spots on your face and body (chloasma), which may be reduced by avoiding the sun and ultraviolet radiation;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, difficulty swallowing, or urticaria potentially with difficulty breathing, contact your doctor immediately. Medications that contain estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

If any of the above conditions worsen or appear for the first time, inform your doctor as soon as possible.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Donabel increases your risk of having a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In the veins (this is called "venous thrombosis", "venous thromboembolism", or VTE).
• In the arteries (this is called "arterial thrombosis", "arterial thromboembolism", or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential to remember that the overall risk of a harmful blood clot due to Donabel is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Donabel, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of having a blood clot in the leg or lung (DVT or PE) with Donabel is small.

• Out of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 will have a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive that contains dienogest and ethinylestradiol, like Donabel, about 8-11 will have a blood clot in a year.

The risk of having a blood clot depends on your personal history (see "Factors that increase your risk of a blood clot" below).

Factors that increase your risk of a blood clot in a vein

The risk of having a blood clot with Donabel is small, but some conditions increase the risk. Your risk is higher:

• if you are overweight (body mass index or BMI over 30 kg/m2).
• if any of your close relatives have had a blood clot in the leg, lung, or elsewhere at a young age (i.e., before the age of about 50).
• if you need an operation or spend a lot of time without getting up due to an injury or illness, or if you have your leg in a cast. You may need to stop using Donabel several weeks before surgery or while you have reduced mobility. If you need to stop using Donabel, ask your doctor when you can start using it again.
• as you get older (especially over 35 years).
• if you have recently given birth.

The risk of having a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the above conditions, even if you are not sure. Your doctor may decide that you should stop using Donabel.

If any of the above conditions change while you are using Donabel, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause a heart attack or stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due to Donabel is very small, but it may increase:

• with age (over 35 years).
• if you smoke. When using a combined hormonal contraceptive like Donabel, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
• if you are overweight.
• if you have high blood pressure.
• if any of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• if you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• if you have migraines, especially migraines with aura.
• if you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• if you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, the risk of having a blood clot may be further increased.

If any of the above conditions change while you are using Donabel, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, inform your doctor.

Pill and cancer

Breast cancer has been observed with a slightly higher frequency in women who take combined oral contraceptives, but it is not known if this is caused by the treatment. For example, it may be due to the fact that more tumors are detected in women who take combined oral contraceptives because they are examined more frequently by their doctor. The occurrence of breast tumors becomes gradually lower after stopping the use of combined oral contraceptives.

3. How to take Donabel

Follow the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Each pack of Donabel contains 21, 3 x 21, 6 x 21, or 13 x 21 film-coated tablets. The pack indicates the days of the week on which you should take the tablets.

You should take the tablets every day at the same time, if necessary with some liquid. You should take one tablet daily for 21 consecutive days. The intake of the tablets from the next pack starts after a 7-day interval without tablets, during which bleeding usually occurs, which usually starts 2-3 days after taking the last tablet and may not have ended before starting the next pack.

Start taking your next pack of Donabel on the 8th day after taking the last tablet. You should start taking the next pack of Donabel even if bleeding is still present. Each new pack will start on the same day of the week as the previous one, making it easier to remember when to start again, and your cycle will always be on the same days of the month.

If you follow the instructions, the contraceptive will protect you from unwanted pregnancy from the first day of treatment.

Taking the first pack of Donabel

If you have not used any hormonal contraceptive in the last month

Start taking a tablet on the first day of your menstrual cycle (the first day of menstruation). You can also start taking it from the 2nd to the 5th day of menstruation, but in this case, you should use an additional barrier method for the first 7 days of tablet intake.

Switching to Donabel from another combined contraceptive (combined oral contraceptive (COC), vaginal ring, combined transdermal patch)

You can start taking Donabel the day after taking the last tablet of your previous contraceptive (meaning there will be no tablet-free interval). If your previous pack also contained inactive tablets (placebo tablets), you can start taking Donabel the day after taking the last active tablet (if you are not sure if the tablets are active, consult your doctor or pharmacist). You can start taking it later, but no later than the day after finishing the rest period of your previous contraceptive (or after taking the last placebo tablet of your previous contraceptive). In the case of a patch or vaginal ring, you should start taking Donabel preferably on the day you remove it and no later than the day you would normally apply it again.

If you follow these instructions, you will not need to use any other contraceptive method.

Switching from a progestogen-only contraceptive (tablet, injection, implant) or progestogen-only intrauterine system (IUS)

You can stop taking progestogen-only tablets at any time and start taking Donabel the next day at the usual time. However, if you have sexual intercourse, use an additional barrier method (barrier method) for the first 7 days of tablet intake.

In the case of an injection, an implant, or an IUS, start taking Donabel on the day you would normally receive the next injection or the day the implant or IUS is removed. However, if you have sexual intercourse, use an additional barrier method (barrier method) for the first 7 days of tablet intake.

After having a baby

If you have just had a baby, your doctor may advise you to start taking Donabel after your first period. However, in some cases, you can start taking the hormonal contraceptive before; please consult your doctor. You should not breastfeed if you take Donabel, unless your doctor has instructed you to do so.

If you are breastfeeding and want to start taking Donabel, talk to your doctor.

After an abortion or miscarriage

Talk to your doctor about the possibility of taking Donabel.

If you take more Donabel than you should

There is no data available on the overdose of Donabel. Overdose may cause nausea, vomiting, and in young women, vaginal bleeding. This vaginal bleeding can occur even in young girls who have not yet had their first period, if they accidentally take this medication. If you have taken more Donabel than you should, contact your doctor.

If you notice that a child has probably taken several tablets, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Donabel

• If it has been less than 12 hourssince you should have taken the tablet, the reliability of the contraceptive is maintained. Take the missed tablet as soon as possible and then continue taking the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more consecutive tablets you miss, the higher the risk of becoming pregnant.

The risk of becoming pregnant is especially high if you miss a tablet at the beginning or end of the pack. Therefore, you should follow the following rules

• If you forget to take more than one tablet

Contact your doctor.

Do not take more than 2 tablets in one day to replace a missed tablet.

If you have forgotten to take several tablets and do not have withdrawal bleeding during the first rest period, you should consider the possibility of pregnancy. In this case, you should talk to your doctor before starting the next pack.

Follow these instructions if you have forgotten to take a tablet:

If you have forgotten a tablet in week 1

If you forget to start taking a new pack or if you forget to take a tablet during the first 7 days, there is a risk that you may be pregnant (if you have had sexual intercourse in the 7 days before missing a tablet). Contact your doctor before starting a new pack.

If you have not had sexual intercourse before missing the tablet, take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. Take additional contraceptive precautions (barrier method - condom) for the next 7 days.

If you have forgotten a tablet in week 2

Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time) and take the next tablet at the usual time. The reliability of the contraceptive is maintained, and you do not need to use additional contraceptive measures.

If you have forgotten a tablet in week 3

If you follow one of the two procedures explained below, you do not need to take additional contraceptive measures:

• Option 1: Take the missed tablet as soon as you remember (even if this means taking two tablets at the same time). From then on, you should continue taking the tablets at the usual time. Then, you should start the next pack immediately after taking the last tablet of the current pack, i.e., without a rest period between packs. It is unlikely that withdrawal bleeding will occur until the end of the second pack, but some spotting or intermenstrual bleeding may occur during the days you are taking the tablets.

or

• Option 2: You can also stop taking the tablets from the current pack. In this case, you should have a tablet-free period of up to 7 days, including the day you missed the tablet, and then continue taking the tablets from the next pack.

If you vomit or have severe diarrhea

If vomiting or severe diarrhea occurs within 3-4 hours after taking a tablet, it is possible that the tablet will not be properly absorbed in the gastrointestinal tract. The situation is similar to that which occurs if you forget to take a tablet. In this case, you should take a tablet as soon as possible, if possible before 12 hours. If more than 12 hours pass, you should follow the instructions in the section “If you forget to take Donabel”.

If you want to delay your period

You can delay the onset of bleeding if, after finishing the previous pack, you continue taking Donabel without a rest period. The intermenstrual bleeding can be delayed until the end of the second pack or, if necessary, for a shorter period. During the intake of the second pack, you may experience some spotting or bleeding while taking the tablets. The regular intake of Donabel will resume after the usual 7-day rest period.

If you want to change the first day of your period

If you follow the instructions for taking the tablets, your period will start approximately on the same day every four weeks. If you need to change this day, you can shorten (but never lengthen) the next rest period by as many days as you want. For example, if your period usually starts on Friday and you want it to start on Tuesday (i.e., three days earlier), you should start the next pack three days earlier than usual. However, if the rest period is too short (3 days or less), withdrawal bleeding may not occur, but spotting or bleeding may occur during the intake of the second pack.

What to do if you have intermenstrual bleeding

In some cases, women taking combined oral contraceptives may experience intermittent spotting or bleeding, especially during the first few months. When your body adapts to the effects of the tablets, irregular bleeding will disappear; this usually happens in the third cycle. If bleeding continues, is more intense, or recurs, talk to your doctor.

What to do if withdrawal bleeding does not occur

If the tablets have been taken correctly, according to the instructions, and you have not had severe vomiting or diarrhea, it is very unlikely that you are pregnant. You should continue taking Donabel as usual.

If you do not have a period for two consecutive times, you might be pregnant. Contact your doctor immediately. You can continue taking Donabel after the pregnancy test and your doctor confirms that you can do so.

If you stop taking Donabel

You can stop taking Donabel at any time you want. If you do not want to become pregnant, ask your doctor about other reliable contraceptive methods.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to Donabel, consult your doctor.

All women who take combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 "What you need to know before taking Donabel".

Severe Adverse Effects

For the most severe adverse effects in women taking combined oral contraceptives, see the "Warnings and Precautions" section. If necessary, seek immediate medical attention.

Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria potentially with difficulty breathing (see also the "Warnings and Precautions" section).

The following is a list of adverse effects that have been associated with the use of Donabel:

Frequent Adverse Effects(may affect up to 1 in 10 people):

• headache,
• breast pain, including breast tenderness and sensitivity.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

• vaginal and external genital inflammation (vaginitis/vulvovaginitis),
• vaginal and genital fungal infections,
• increased appetite,
• depressive mood,
• dizziness,
• migraine,
• high or low blood pressure,
• abdominal pain (including upper and lower abdominal pain, discomfort/bloating),
• nausea, vomiting, or diarrhea,
• acne,
• alopecia (hair loss),
• rash (including the appearance of spots on the skin),
• itching (in some cases all over the body),
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), light bleeding (hypomenorrhea), irregular bleeding, and absence of bleeding,
• intermenstrual bleeding (vaginal/uterine hemorrhage),
• breast enlargement, including breast swelling,
• breast edema,
• dysmenorrhea (menstrual pain),
• vaginal discharge,
• ovarian cysts,
• pelvic pain,
• fatigue, including weakness (asthenia) and discomfort (fatigue, weakness, and general malaise),
• changes in body weight (increase, loss, or fluctuations).

Rare Adverse Effects(may affect up to 1 in 1,000 people):

• inflammation of the ovaries or fallopian tubes,
• inflammation of the urinary tract,
• inflammation of the bladder (cystitis),
• inflammation of the breast (mastitis),
• fungal and yeast infections,
• cold sores,
• flu (influenza),
• bronchitis,
• sinus infection (sinusitis),
• upper respiratory tract infections,
• viral infections,
• uterine fibroids (benign tumors in the uterus),
• breast lipomas (benign tumors in breast tissue),
• anemia,
• hypersensitivity (allergic reactions),
• masculinization (virilism),
• loss of appetite (anorexia),
• depression,
• mental disorders,
• insomnia,
• sleep disorders,
• aggression,
• ischemic stroke (reduced or interrupted blood supply to the brain),
• cerebrovascular disorders,
• muscle tone change - dystonia (muscle disorders that can cause abnormal postures or movements),
• dry or irritated eyes,
• oscillopsia (eye disorder in which objects appear to be moving) or other vision disorders,
• sudden hearing loss,
• tinnitus,
• vertigo,
• hearing impairment,
• cardiovascular disorders (disorders of blood supply to the heart),
• rapid heart rate (tachycardia),
• harmful blood clots in a vein or artery, for example:

• in a leg or foot (i.e., deep vein thrombosis),
• in a lung (i.e., pulmonary embolism),
• heart attack,
• stroke,
• mild or temporary stroke-like symptoms, known as transient ischemic attack (TIA),
• blood clots in the liver, stomach/intestine, kidneys, or eye.

• increase in diastolic blood pressure (the lowest blood pressure value reached between two heartbeats),
• orthostatic hypotension (dizziness or fainting when standing up after sitting or lying down),
• hot flashes,
• varicose veins,
• venous disorders, vein pain,
• asthma,
• deep breathing,
• stomach inflammation,
• intestinal inflammation,
• indigestion (dyspepsia),
• skin reactions,
• skin problems including allergic skin reactions, neurodermatitis/atopic dermatitis, eczema, psoriasis,
• excessive sweating,
• chloasma (brown-gold spots, also called pregnancy spots, especially on the face),
• pigmentation disorders/increased pigmentation,
• seborrhea (oily skin),
• dandruff,
• hirsutism (male hair growth),
• orange peel skin,
• vascular spider (blood vessels with a spider-like appearance, with a central red spot on the skin),
• back pain,
• discomfort in bones and muscles,
• muscle pain,
• pain in arms and legs,
• abnormal cell growth on the surface of the cervix (cervical dysplasia),
• pain or cysts in the uterine appendages (fallopian tubes and ovaries)
• breast cysts,
• fibrocystic breast disease (benign growths in the breasts),
• pain during intercourse (dyspareunia),
• breast secretion (galactorrhea),
• menstrual disorders,
• chest pain,
• peripheral edema (fluid retention in the body),
• flu-like illness,
• inflammation.

Adverse reactions that have been reported with the use of oral contraceptives and for which the exact frequency is unknown are: mood changes, increased or decreased sexual desire (libido), intolerance to contact lenses, urticaria, skin disorders such as erythema nodosum or multiforme, breast secretion, fluid retention.

The risk of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

Description of Selected Adverse Reactions

Adverse reactions with very low incidence or late onset of symptoms related to the group of combined oral contraceptives are listed below (see also "Do not take Donabel" and "What you need to know before taking Donabel").

Tumors

• The frequency of breast cancer diagnosis among users of hormonal contraceptives is slightly increased. Since breast cancer rarely occurs in women under 40 years of age, the risk of developing breast cancer is minimal compared to the general risk. It is not known if there is a causal relationship with the use of combined oral contraceptives.
• Liver tumors (benign and malignant).

Other Conditions

• women with hypertriglyceridemia (the increase in the amount of fat in the blood may cause a higher risk of pancreatitis during the use of combined oral contraceptives),
• increased blood pressure,
• onset or worsening of conditions whose association with combined oral contraceptives is unclear: jaundice and/or itching associated with cholestasis (interruption of bile output), gallstones, porphyria (metabolic disorder), systemic lupus erythematosus (chronic autoimmune disease), hemolytic-uremic syndrome (a disease caused by blood clot formation), a nervous disease called Sydenham's chorea, gestational herpes (a blistering disease that occurs during pregnancy), hearing loss caused by otosclerosis,
• liver impairment,
• changes in glucose tolerance or peripheral insulin resistance,
• Crohn's disease, ulcerative colitis,
• chloasma (yellow-brown spots on the skin).

Interactions

Unexpected bleeding and/or contraceptive failure may be due to interactions between other medications and oral contraceptives (e.g., St. John's Wort, medications for treating epilepsy, tuberculosis, HIV infection, and other infections). See also "Other medications and Donabel".

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

More Information on Oral Contraceptives

Combined oral contraceptives may also produce health benefits unrelated to contraception.

Menstrual bleeding may be weaker and shorter. This may mean a lower risk of anemia. The pain associated with menstruation may be less or disappear completely.

Additionally, it has been reported that users of pills containing 50 micrograms of ethinylestradiol (high-dose pill) have a lower incidence of certain serious diseases. These include benign breast diseases, ovarian cysts, pelvic infections (inflammatory diseases of the small organs of the pelvis), ectopic pregnancy (the fetus develops outside the uterus), and endometrial and ovarian cancer. This may also apply to the use of a low-dose pill, but so far it has only been confirmed for endometrial and ovarian cancer.

5. Storage of Donabel

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Donabel

• The active ingredients are dienogest and ethinylestradiol. Each tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• The other ingredients are:

Tablet core: lactose monohydrate, magnesium stearate, cornstarch, povidone 30, talc.

Coating: Opaglos 2 clear, which contains: sodium carmellose, glucose, maltodextrin, sodium citrate dihydrate, soy lecithin.

Appearance of the Product and Package Contents

Donabel is a film-coated tablet that is white, round, and biconvex.

Donabel is available in packages containing 21, 3 x 21, 6 x 21, and 13 x 21 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n, Polígono Industrial Navatejera

24193 Villaquilambre, León

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

CZ: Calleto

ES: Donabel 2 mg/0.03 mg film-coated tablets EFG

PT: Denille 2 mg + 0.03 mg film-coated tablet

EE: Ammily 2 mg/0.03 mg

LT: Ammily 2 mg/0.03 mg film-coated tablets

LV: Ammily 2 mg/0.03 mg film-coated tablets

IT: Effiprev 2 mg/0.03 mg

FR: Dienopil 2 mg/0.03 mg

LU: Louise 2 mg/0.03 mg

BE: Louise 2 mg/0.03 mg

Date of the Last Revision of this Leaflet:January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/